Binaural beats for cognitive function in older adults with mild cognitive impairment in nursing homes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study will enroll older adults with mild cognitive impairment living in nursing homes to test a non-drug approach using 10-Hz alpha-frequency binaural beats delivered via headphones for 30 minutes each day over 14 consecutive days. Researchers will measure cognitive function, sleep quality, anxiety, and depressive symptoms at baseline, after the 14-day intervention, and at a 2-week follow-up. The goal is to determine whether binaural beats are a safe and feasible option to support cognitive health in this population. Safety and tolerability will be monitored throughout the study. No information is provided about a control group in the available details.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age 60 years or older.
2. Not previously diagnosed with dementia.
3. Meets the diagnostic criteria for mild cognitive impairment, with Montreal Cognitive Assessment scores adjusted by education level, Mini-Mental State Examination score \>= 24, and Activities of Daily Living score \< 23.
4. Has lived in a nursing home for more than 2 months and plans to continue living there during the study period.
5. No hearing impairment; Hearing Handicap Inventory for the Elderly-Screening Version score \< 8, and able to hear binaural beats through both ears.
6. Conscious and able to cooperate with questionnaires and scale assessments.
7. Has not taken medications that may affect cognitive function within 3 to 6 months before the intervention.

Exclusion Criteria:

1. Severe physical disease, major organ failure, or advanced malignant tumor.
2. Diagnosed depression or other psychiatric disorders.

Withdrawal Criteria:

1. Serious adverse events during the study, such as falls, disease recurrence, discomfort caused by the intervention audio, death, or other conditions making continued participation unsuitable.
2. Voluntary withdrawal from the study.

Removal Criteria:

1. Incomplete data resulting in missing information.
2. Missing three or more intervention sessions within 2 weeks without following intervention instructions.
3. Receiving other treatments or interventions related to cognitive function during the trial.

Where it's running

• Jintaiyang Jingguan Elderly Care Apartment
  Shenyang, Liaoning, China Recruiting
• Jintaiyang Elderly Care Center, Huanggu Branch
  Shenyang, Liaoning, China Recruiting
• Renai Changwan Elderly Care Home, Dadong District
  Shenyang, Liaoning, China Recruiting

Study contacts

• Study coordinator: Liu Yu Yu Liu, Professor
• Email: liuyu@cmu.edu.cn
• Phone: +8618640068209

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.